serim.comWAVICIDE-OPA MEC Indicator
Serim Research Corporation
SERIM RESEARCH CORP.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1833387 | 1833387 | SERIM RESEARCH CORP. | 1 | N | 2026-01-01 | 3506 Reedy Dr ELKHART IN US 46514 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M1745100A1 | Serim® GUARDIAN™ Residual Chlorine Test Strips - Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. | 800-542-4670 | customerservice@serim.com |
| M17451052 | Serim® GUARDIAN™ Residual Peroxide Test Strips - Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants. | 800-542-4670 | customerservice@serim.com |
| M17451092 | Serim® GUARDIAN™ HiSENSE™ Test Kit - The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate. | 800-542-4670 | customerservice@serim.com |
| M17451190 | Serim® GUARDIAN™ Blood Leak Test Strips - Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure. | 800-542-4670 | customerservice@serim.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 12088 | 1495385627 | K953632 | SERIM PYLORITEK TEST KIT | LYR | 1995-12-18 |
| 12088 | 1168168434 | K952215 | SERIM HISENSE TEST KIT | FIP | 1995-08-09 |
| 12088 | 1501580540 | K945491 | SERIM(TM) BICARB PH REAGENT STRIPS | MNV | 1995-02-01 |
| 12088 | 1605647367 | K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS | LIF | 1992-04-09 |
| 12088 | 1294944480 | K913943 | SERIM DISINTEK REAGENT STRIPS | MED | 1992-03-26 |
| 12088 | 1679497856 | K910320 | SERIM PERACETIC ACID REAGENT STRIPS | JOJ | 1991-05-01 |
| 12088 | 1419632196 | K901734 | SERIM RESIDUAL CHLORINE TEST KIT | FKJ | 1990-09-13 |
| 12088 | 1853380757 | K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT | LIF | 1990-07-11 |
| 12088 | 1114913146 | K120652 | RAPICIDE OPA-28 TEST STRIP | JOJ | 2012-10-12 |
| 12088 | 1579012393 | K082352 | SERIM DISINTEK OPA TEST STRIP | JOJ | 2008-09-25 |
| 12088 | 2053531576 | K081370 | SERIM DISINTEK OPA TEST STRIP | JOJ | 2008-07-11 |
| 12088 | 1217442953 | K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | MSY | 2008-05-06 |
| 12088 | 1871992185 | K012115 | SERIM BLOOD LEAK TEST STRIP-2 | FJD | 2001-11-30 |
| 12088 | 1667447889 | K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | LJX | 2000-05-05 |
| 12088 | 1318400817 |
Product Codes Associated With Registrations
PMN
QwikCheck Chemical Indicators
Serim Research Corporation
RAPICIDE OPA-28 TEST STRIP
SERIM RESEARCH CORP.
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
SERIM RESEARCH CORP.
SERIM DISINTEK GTA 2.1%, MODEL: 5164
SERIM RESEARCH CORP.
SERIM DISINTEK OPA TEST STRIP
SERIM RESEARCH CORP.
SERIM DISINTEK OPA TEST STRIP
SERIM RESEARCH CORP.
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
SERIM RESEARCH CORP.
SERIM PERACETIC ACID CHEMICAL INDICATOR
SERIM RESEARCH CORP.
SERIM DIALYSATE MONITOR TEST STRIP
SERIM RESEARCH CORP.
PYLORITEK VP TEST KIT 5140VP
SERIM RESEARCH CORP.
SERIM BLOOD LEAK TEST STRIP-2
SERIM RESEARCH CORP.
SERIM LEUKOCYTE ESTERASE TEST STRIPS
SERIM RESEARCH CORP.
CIDEX OPA SOLUTION TEST STRIP
SERIM RESEARCH CORP.
SERIM BLOOD LEAK TEST STRIP
SERIM RESEARCH CORP.
SPOROX TEST STRIPS
SERIM RESEARCH CORP.
SERIM PYLORITEK TEST KIT
SERIM RESEARCH CORP.
SERIM HISENSE TEST KIT
SERIM RESEARCH CORP.
SERIM(TM) BICARB PH REAGENT STRIPS
SERIM RESEARCH CORP.
WAVICIDE MONITOR STRIPS
SERIM RESEARCH CORP.
SERIM PYLORITEK REAGENT STRIPS
SERIM RESEARCH CORP.
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
SERIM RESEARCH CORP.
SERIM DISINTEK REAGENT STRIPS
SERIM RESEARCH CORP.
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
SERIM RESEARCH CORP.
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
SERIM RESEARCH CORP.
SERIM PERACETIC ACID REAGENT STRIPS
SERIM RESEARCH CORP.
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
SERIM RESEARCH CORP.
SERIM RESIDUAL CHLORINE TEST KIT
SERIM RESEARCH CORP.
SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
SERIM RESEARCH CORP.
GUDID
Serim® DISINTEK™ GTA 1.5% Test Strips - Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or MetriCide® reusable glutaraldehyde high-level disinfectants.
2016-09-08
Serim® DISINTEK™ OPA Test Strips - Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.
2016-09-08
Serim® GUARDIAN™ Blood Leak Test Strips - Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.
2017-02-12
Serim® GUARDIAN™ HiSENSE™ Test Kit - The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.
2016-09-19
Serim® GUARDIAN™ Residual Peroxide Test Strips - Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.
2016-09-08
Serim® GUARDIAN™ Residual Chlorine Test Strips - Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
2016-08-29
Serim® PyloriTek® Test Kit - The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.
2016-09-19
Serim® GUARDIAN™ Blood Leak Test Strips - Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.
2026-01-29
Serim® GUARDIAN™ Residual Formaldehyde Test Strips - Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis.
2016-09-08
Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips - SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.
2016-09-08
Serim® PyloriTek® Test Kit - The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.
2016-09-19
Serim® GUARDIAN™ Bicarb pH II Test Strips - Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
2016-09-19
Serim® GUARDIAN™ Residual Chlorine Test Strips - Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
2016-08-29
Serim® GUARDIAN™ Peracetic Acid Test Strips - SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
2016-09-08
Serim® PeriScreen™ Test Strips - Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.
2016-09-08